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A clinical trial to assess the impact of Yoga on vasomotor symptoms in post-surgical breast cancer patients undergoing hormone therapy

A randomized controlled trial to evaluate the effect of yoga in preventing adjuvant endocrine therapy associated vasomotor symptoms - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087272
Enrollment
226
Registered
2025-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Structured Yoga: Participants enrolled in structured Yoga group will be engaged for a total duration of 12 weeks undergoing 15mins of structured yoga thrice weekly. Intervention2: Struc

Sponsors

American Society of Clinical Oncology (ASCO)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed hormone-receptor positive breast cancer (Stage I III). 2) Planned to start ET (tamoxifen, ovarian function suppression, or aromatase inhibitors). 3) ECOG performance status 0-2. 4) Ability to perform yoga exercises as per physician s discretion

Exclusion criteria

Exclusion criteria: 1) Pre-existing moderate to severe vasomotor symptoms before ET initiation. 2) Medical conditions limiting participation in yoga (e.g., severe osteoarthritis, interstitial lung disease, cardiac failure).

Design outcomes

Primary

MeasureTime frame
Primary Endpoint: 1. Proportion of patients experiencing moderate to severe hot flashes within 12 weeks of intervention Timepoint: Assessed at baseline, 6, 12, and 24 weeks.

Secondary

MeasureTime frame
Secondary Endpoints: 1. Quality of Life (QoL) 2. ET AdherenceTimepoint: Secondary Endpoints: 1. Quality of Life (QoL): Assessed using EORTC QLQ-C30 at baseline, 6, 12, & 24 weeks. 2. ET Adherence: Measured by patient-reported adherence diaries & dose density calculation at baseline, 6, 12, & 24 weeks.

Countries

India

Contacts

Public ContactAtul Batra

All India Institute of Medical Science, New Delhi

batraatul85@gmail.com9013078407

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026